Add-on to Micamlo BP Trial

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Telmisartan + amlodipine; Drug: Placebo; Drug: hydrochlorothiazide

• Registration Number: NCT01975246
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg +hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ amlodipine 5 mg (T80/A5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ amlodipine 5 mg. Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/A5 mg.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-29
• Study First Submitted QC: 2013-10-29
• Study Start: 2013-11
• Study First Posted: 2013-11-03
• Primary Completion: 2014-06
• Study Completion: 2014-07
• Disposition First Submitted: 2014-07-23
• Disposition First Submitted QC: 2014-07-23
• Disposition First Posted: 2014-07-24
• Status Verified: 2016-10
• Results First Submitted: 2016-10-06
• Results First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Results First Posted: 2016-11-29
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan+amlodipine+HCTZ	Telmisartan + amlodipine	telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet
Telmisartan+amlodipine	Telmisartan + amlodipine	telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet
Telmisartan+amlodipine	Placebo	telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and placebo matching hydrochlorothiazide 12.5 mg tablet
Telmisartan+amlodipine+HCTZ	hydrochlorothiazide	telmisartan 80 mg + amlodipine 5 mg fixed dose combination (FDC) and hydrochlorothiazide (HCTZ) 12.5 mg tablet

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.	baseline and week 8	Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.	baseline and week 8	Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.
The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period	baseline and week 8	Patients with trough seated DBP =\>90 mmHg or trough seated SBP \>=140 mmHg at baseline were analysed.

Trial Locations

Locations (30)

1348.1.022 Boehringer Ingelheim Investigational Site; 🇯🇵 Mihama-ku, Chiba, Chiba, Japan

1348.1.004 Boehringer Ingelheim Investigational Site; 🇯🇵 Miyagino-ku, Sendai, Miyagi, Japan

1348.1.025 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1348.1.033 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan

1348.1.021 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku,Tokyo, Japan

1348.1.028 Boehringer Ingelheim Investigational Site; 🇯🇵 Itoshima, Fukuoka, Japan

1348.1.027 Boehringer Ingelheim Investigational Site; 🇯🇵 Katsushika-ku, Tokyo, Japan

1348.1.024 Boehringer Ingelheim Investigational Site; 🇯🇵 Itabashi-ku, Tokyo, Japan

1348.1.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Kishiwada, Osaka, Japan

1348.1.017 Boehringer Ingelheim Investigational Site; 🇯🇵 Moriya, Ibaraki, Japan

1348.1.013 Boehringer Ingelheim Investigational Site; 🇯🇵 Naka-ku,Yokohama,Kanagawa, Japan

1348.1.016 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku,Sapporo,Hokkaido, Japan

1348.1.009 Boehringer Ingelheim Investigational Site; 🇯🇵 Kita-ku, Osaka, Japan

1348.1.029 Boehringer Ingelheim Investigational Site; 🇯🇵 Kita-ku, Osaka, Japan

1348.1.014 Boehringer Ingelheim Investigational Site; 🇯🇵 Kiyose,Tokyo, Japan

1348.1.018 Boehringer Ingelheim Investigational Site; 🇯🇵 Nishi-ku, Fukuoka, Fukuoka, Japan

1348.1.008 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan

1348.1.026 Boehringer Ingelheim Investigational Site; 🇯🇵 Sapporo, Hokkaido, Japan

1348.1.015 Boehringer Ingelheim Investigational Site; 🇯🇵 Atsubetsu-ku,Sapporo,Hokkaido, Japan

1348.1.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiyoda-ku, Tokyo, Japan

1348.1.006 Boehringer Ingelheim Investigational Site; 🇯🇵 Bunkyo-ku, Tokyo, Japan

1348.1.005 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiyoda-ku, Tokyo, Japan

1348.1.031 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiyoda-ku, Tokyo, Japan

1348.1.007 Boehringer Ingelheim Investigational Site; 🇯🇵 Okinawa, Okinawa, Japan

1348.1.003 Boehringer Ingelheim Investigational Site; 🇯🇵 Koto-ku, Tokyo, Japan

1348.1.020 Boehringer Ingelheim Investigational Site; 🇯🇵 Sakaide, Kagawa, Japan

1348.1.032 Boehringer Ingelheim Investigational Site; 🇯🇵 Suita, Osaka, Japan

1348.1.019 Boehringer Ingelheim Investigational Site; 🇯🇵 Takamatsu, Kagawa, Japan

1348.1.023 Boehringer Ingelheim Investigational Site; 🇯🇵 Toshima-ku, Tokyo, Japan

1348.1.030 Boehringer Ingelheim Investigational Site; 🇯🇵 Chuo-ku, Tokyo, Japan